PSURs

Conference Date: 28-29 Sep 2009
Conference Ref: A9-4309
Fee: $1900
Venue: Sheraton Boston Hotel

This 2-day workshop will include background and current status of the requirements for PSURs, experience with meeting Regulators’ expectations, practicalities of document production, and consideration of anticipated developments in the field.  It critically examines the PSUR content (including PSUR Addendum and Summary Bridging Reports) and process from the pharmacovigilance and medical writing perspectives.

BENEFITS OF ATTENDING

• Understand the Background and Current Status of the Requirements for PSURs
• Discover How to Produce a High Quality PSUR & the Practicalities of Document Production
• Gain an Overview of Relevant Guidance Documents and the Differences between EU & US
• Ensure you Know How to Meet Regulators’ Expections
• Discuss Future Developments

WHO SHOULD ATTEND

This meeting will be of interest to personnel from Pharmacovigilance groups, Research and Development Departments, Adverse Event Monitoring Units,  Regulatory Affairs and Registration Departments and Drug Safety Officers. It will benefit those involved and interested in pharmacovigilance, PSUR production, and the global regulation of medicines.

With:
Dr John Price Vice-President and Head of Regulatory Analysis and Documentation, Safety and Risk Management, Pfizer Inc., USA
and
Kay Samulak Senior Director, Oncology Therapeutic Area - Regulatory Analysis and Documentation within Safety and Risk Management Organization, Pfizer Inc., USA

Click here to book your place on this important event.